Identity
- Trade Name
- Heka EUDAMED
- Device Name
- Heka cold / hot pack EUDAMED
- Model / Reference
- OT0300-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715886028636 EUDAMED
- Basic UDI-DI
- 8715886PPHotColdPackRT EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- The HEKA cold / hot pack is a reusable cold / hot compress, including protective cover. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Hot/cold therapy pack, reusable
Heka by Allion BV h.o.d.n. van Heek Medical — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8715886PPHotColdPackRT | Class I | Active |
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Manufacturer
- Manufacturer
- Allion BV h.o.d.n. van Heek Medical
- EUDAMED SRN
- NL-PR-000015343
Sources (1)
- EUDAMED 8a47b2d0-1bbf-4d5e-ac8b-0e396d546f66 61 fields · synced Jun 19, 2026